Ea 65
FDA 510(k) K812086 · Surgipath
510(k) numberK812086
Submission
- Device name
- Ea 65
- Applicant
- Surgipath
Mchenry, IL, US - Received
- July 22, 1981
- Decision date
- August 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HZJ – Stain, Papanicolau
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
Other 510(k)s with product code HZJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843427 | Gill Papanicolaou Stain EA-1 & 2 OG-6HZJ · Traditional | Accra Laboratories, Inc. | 10/02/1984SE |
| K842739 | Pap Stain, EA-36HZJ · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842735 | Pap Stain EA-65HZJ · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842738 | Pap Stain EA-50HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K842736 | Pap Stain, OG-6HZJ · Traditional | E K Ind., Inc. | 08/17/1984SE |
| K840054 | Papanicolaou Stain Sys HT40HZJ · Traditional | Sigma Chemical Co. | 02/17/1984SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | Volu Sol Medical Industries | 08/03/1982SE |
| K820027 | Modified Ea 50HZJ · Traditional | Surgipath | 02/04/1982SE |
| K812087 | Ea 50HZJ · Traditional | Surgipath | 08/13/1981SE |
| K800325 | Volu-Sol Histo./Cyto. Stain Mod. #EA65HZJ · Traditional | Volu Sol Medical Industries | 02/26/1980SE |
More from Volu Sol Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K820027 | Modified Ea 50HZJ · Traditional | 02/04/1982SE |
| K812940 | 10% Neutral Buffered Formalin ConcentIFP · Traditional | 12/10/1981SE |
| K812087 | Ea 50HZJ · Traditional | 08/13/1981SE |
| K811826 | Eosin YHYB · Traditional | 07/10/1981SE |
| K811825 | Orange G-6HZH · Traditional | 07/10/1981SE |
| K810836 | Decalcifier IIKDX · Traditional | 04/23/1981SE |
| K810760 | Gill's Hematoxylin #3 · Traditional | 04/14/1981SE |
| K810759 | Gill's Hematoxylin #2HYJ · Traditional | 04/14/1981SE |
| K810758 | Gill's Hematoxylin #1HYJ · Traditional | 04/14/1981SE |
| K810733 | Harris HematoxylinHYK · Traditional | 04/14/1981SE |
Questions and answers
When was Ea 65 cleared by the FDA?
Ea 65 (K812086) received a 510(k) decision of Substantially Equivalent on August 13, 1981, 22 days after the submission was received.
What is the product code of K812086?
The FDA product code is HZJ – Stain, Papanicolau, a Class I (low risk) device regulated under 21 CFR 864.1850.